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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Miavana Wholesale Company, Inc. 07-Jul-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  555 Winderley Pl. Ste. 200
Maitland, FL 32751




July 7, 2003

Armando F. Coronel, President
Miavana Wholesale Company, Inc.
2175 NW 23rd Court
Miami, Florida 33142

Dear Mr. Coronel:

On March 19, 20, and 24, 2003, we inspected your seafood processing facility, located at the above address. We found that you have serious deviations from the Seafood HACCP Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) and Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (cGMP), Part 110 (21 CFR 110). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 USC. 342(a)(4). Accordingly, your Scombrotoxin (histamine) forming fresh fish, including herring and mackerel, are.adulterated in that these products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act, Seafood HACCP Regulations, and cGMP Regulations through links in FDA?s homepage at www.fda.gov.

The deviations, observed during the inspection and upon further examination of the documents collected during that inspection, are as follows:

Domestic HACCP

1. ??????? You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for fresh herring and mackerel to control the food safety hazard of Scombrotoxin (histamine) formation.

Import HACCP

1.      You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have a product specification for imported from [redacted]

2.?? You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for fresh, salted raw mackerel and herring manufactured by [redacted] in [redacted]

We may take further action, if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as monitoring records, revised HACCP plans, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deviations.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP Regulations, and the Current Good Manufacturing Practices Regulations for Human Food (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Diane J. Englund, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issue in this letter, please contact Ms. Englund at (407) 475-4741.

Kendall W. Dester? for
Emma R. Singleton
District Director
Florida District